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Regulations last checked for updates: May 14, 2025

Title 21 - Food and Drugs last revised: May 12, 2025
All TitlesTitle 21Chapter IPart 864 - PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
  • Subpart A [§ 864.1 - § 864.9] - Subpart A—General Provisions
  • Subpart B [§ 864.1850 - § 864.1870] - Subpart B—Biological Stains
  • Subpart C [§ 864.2220 - § 864.2875] - Subpart C—Cell And Tissue Culture Products
  • Subpart D [§ 864.3010 - § 864.3875] - Subpart D—Pathology Instrumentation and Accessories
  • Subpart E [§ 864.4010 - § 864.4400] - Subpart E—Specimen Preparation Reagents
  • Subpart F [§ 864.5200 - § 864.5950] - Subpart F—Automated and Semi-Automated Hematology Devices
  • Subpart G [§ 864.6100 - § 864.6700] - Subpart G—Manual Hematology Devices
  • Subpart H [§ 864.7010 - § 864.7925] - Subpart H—Hematology Kits and Packages
  • Subpart I [§ 864.8100 - § 864.8950] - Subpart I—Hematology Reagents
  • Subpart J [§ 864.9050 - § 864.9875] - Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
  • Subpart K [§ 864.9900 - § 864.9900] - Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
authority: 21 U.S.C. 351,360,360c,360e,360j,360
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